Integration of Education Based-Application and "CARE Coaching Model" in Management of Type 2 Diabetes Mellitus Patients Using Insulin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Integrasi Edukasi Berbasis Aplikasi Dan "CARE Coaching Model" Pada Pengelolaan Pasien Diabetes Mellitus Tipe 2 Yang Menggunakan Insulin

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04271631
• Other study ID #: PS001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: February 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetes mellitus is increasing in incidence worldwide. The goal of management of diabetes is to achieve blood sugar control by minimizing side effects and preventing short and long term complications. Self-management becomes important in the management of diabetes mellitus. The use of mobile phone applications provides opportunities for the management of diabetics. In addition, health coaching is one of method used for empowering patients with chronic diseases, such as diabetes. This study aims to evaluate the impact of Mobile Application-Based Diabetes Education and health coaching in management of type 2 diabetes mellitus.

Description:

A randomized control trial, pre and post study involving 105 subjects randomized into 3 arms:

• Control : received conventional education group

• Intervention 1 : received conventional education group + mobile application-based diabetes education

• Intervention 2 : received mobile application-based diabetes education + health coaching

Conventional education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes.

Mobile application-based diabetes education is using DM Educorner (Diabetes Mellitus Education Corner) availablle in Google PlayStore. Education contents was delivered in articles, video and infographics.

Health coaching was given by a coach, a healthcare professional who undergo training to become a coach. Health coaching delivered as face to face between subjects and coach.

Laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: May 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 2 Diabetes Mellitus

• multiple daily insulin injection (basal and rapid, or mixed)

• 30 - 65 years old

• HbA1c > 8%

• Using smartphone in daily lives.

• Willing to follow the research by signing an informed consent

Exclusion Criteria:

• Patients with cognitive disease (such as dementia)

• Patients with hearing or sight problem

• Unable to live independently on daily basis

• Patients who have disease that may affect Hba1c such as hemolytic anemia, thalassemia

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Mobile Application-Based Diabetes Education
Additional education was given using application, subjects were asked to open the application at least once a day
• Health Coaching
Health coaching was given as face to face with a coach

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine, Universitas Indonesia	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Hb1A1c at 3 months	Glycemic control	3 months
Secondary	Change from Baseline Fasting plasma glucose at 3 months	Glycemic control	3 months after intervention
Secondary	Change from Baseline 2 hours-post prandial plasma glucose at 3 months	Glycemic control	3 months after intervention
Secondary	Change from Baseline Total cholesterol at 3 months	Diabetes Mellitus control	3 months after intervention
Secondary	Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months	Diabetes Mellitus control	3 months after intervention
Secondary	Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months	Diabetes Mellitus control	3 months after intervention
Secondary	Change from Baseline Triglycerides at 3 months	Diabetes Mellitus control	3 months after intervention
Secondary	Mean of intake calories from food Record	mean calorief from diet intake in 3 days	at baseline, 3 months after intervention
Secondary	Global Physical Activities Questionnaire	Questionnaire about physical activities in whole one week. Divided into 3 categories: low, moderate, high. Every categories describe duration and numbers of day being active during 1 weeks and not for judging it is good or worse.	at baseline, 3 and 6 months after intervention
Secondary	Self-Monitoring Blood Glucose	Notes of daily blood glucose	through study completion, an average of 3 months